FDA Panel Recommends Approval for Two New Abuse-Deterrent Opioids, But Says No to a Third

June 30, 2016
By
Novus Medical Detox Center

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Close to a dozen abuse-deterrent prescription opioid painkillers have been
approved by the FDA Panel over the past few years. Already this year,
three more companies have submitted new opioid painkillers with abuse-deterrent
formulation for approval.

(Abuse deterrence means that the pills, patches and liquids are formulated
to make them discouragingly difficult to crush, snort, dissolve or inject.)

The investment by drug makers in developing new technology to discourage
abuse has been enormous. And the efforts are continuing, as seen by the
three latest submissions to the FDA and rumors that there are many more
on the way.

Seeking approval for new abuse-deterrent opioid painkillers this year were:

Teva Pharmaceuticals for its new Vantrela™ abuse-deterrent extended-release
hydrocodone

Pfizer for its new Troxyca™ abuse-deterrent extended-release oxycodone/naltrexone

KempPharm for its new Apadaz™ abuse-deterrent benzhydrocodone/acetaminophen

The joint FDA committee tasked with recommending the approval or disapproval
of these new abuse-deterrent painkillers included the Anesthetic and Analgesic
Drug Products Advisory Committee (AADPAC) and the Drug Safety Risk Management
Advisory Committee (DSaRM).

The joint committee was tasked with evaluating each product's effectiveness
for the purposes claimed, both as a painkiller and its abuse-deterrent
properties.

The committee's findings are not final FDA approval. Committees make
recommendations to the FDA executive bodies that make the final decisions.

Each company needed a positive recommendation for the abuse deterrence
aspect as well as for its intended use as a pain pill. Abuse-deterrence
means a great deal in today's opioid painkiller market, and without
approval, they can't make that claim or state it on their labels.

Teva's Vantrela™

Israeli drugmaker Teva Pharmaceutical was successful on both fronts, although
the committee was not overwhelmingly positive.

And the committee also voted, in three separate votes, to approve labeling
stating that Vantrela is abuse-deterrent for oral (14-to-3), intranasal
(14-to-3) and intravenous (16-to-1) routes of abuse.

As reported in
MedPage Today, many committee members approval "came with some hesitation."
They said that Vantrela appeared to be "an incremental step in the
right direction" but that there needs to be better "outcome
measures" for reductions in abuse for judging the effectiveness of
abuse-deterrent reformulations. Improved outcomes for the treatment of
pain should also be more clearly measurable, they said.

"It's not any worse than other extended-release opioids on the
market," said panelist Tobias Gerhard, PhD, of Rutgers University,
who voted against approval of Vantrela. "But if we don't start
to re-think how we approve and regulate opiates, then we will never really
change the problems we have with the opioid epidemic."

The three disapprovals for the oral route abuse-deterrence was based on
data from the FDA's required studies, which suggested that the drug
is "easily extracted with a commonly available solvent." Nevertheless
the drug received a majority pass on all points.

Pfizer's Troxyca™

This is Pfizer's second abuse-deterrent opioid. Embeda™, a combination
of morphine and naltrexone, is already on the market. Embeda didn't
receive abuse-deterrent labeling when it was approved in 2008, but finally
received approval for labeling in 2014.

The new drug, Troxyca, employs the same technique of combining naltrexone
with the active opioid. Naltrexone is a potent opioid antagonist that
blocks the euphoria. You can treat the pain but you can't get high.

The panelists voted in favor of abuse-deterrent labeling for the intranasal
(11-to-4) and intravenous (9-to-6) routes of abuse, but voted against
labeling the drug abuse deterrent for oral abuse (6-to-9).

These were all close votes, and such close votes are often considered "null"
among FDA observers, said
MedPage Today. This often means that the final decisions for approval or denial can go
either way when the FDA makes its final decisions.

According to news reports, Pfizer is continuing its dialog with the FDA.

Apadaz™

As for KemPharm's Apadaz, an abuse-deterrent extended-release formulation
of hydrocodone and benzoic acid combined with acetaminophen, it received
good marks as a painkiller but failed to convince the committee that it's
an effective abuse deterrent.

The committee voted 16-to-4 that Apadaz should be approved for moderate
to severe acute pain. However the FDA gave a serious thumbs down on abuse
deterrence, voting 18-2 that the drug should not be labeled as abuse-deterrent.

The disapproval immediately impacted KemPharm's share prices, illustrating
how important the abuse-deterrent label is in the marketplace.

"The vote against the compound's abuse-deterrent properties sent
shares (NASDAQ:KMPH) into a tailspin...to close at $6.91, down $8.76,
or 55.9 percent," reported
BioWorld, the daily biopharmaceutical news journal. Investors were counting on
approval to "differentiate the product in a tough competitive landscape,"
said the report.

The company received the FDA's standard Complete Response Letter (CRL),
a formal statement summarizing the FDA's findings. It states that
the review is complete, and that the drug application "is not ready
for approval in its present form." CRL's include the specific
deficiencies and, where feasible, lays out the recommendations for making
a new application more likely to receive approval.

Bottom line

The pharma industry's moves to create more abuse deterrent opioids
is a bright positive in an often bleak landscape of drug overdose and injury.

The first company to produce an abuse-deterrent opioid was Purdue Pharma,
maker of the most notorious and abused prescription painkiller in the
soaring, decade-long addiction epidemic, OxyContin. The company stepped
up in 2010 with a new abuse-deterrent OxyContin, and has added several
more similar drugs since. Numerous other drug makers, both brand name
and generic, have joined the abuse-deterrent parade.

Here at Novus, we see this as a good thing. Even though it may seem only
a small part of the battle, we support every effort that helps reduce
the opioid drug epidemic and helps people get their lives back from drug
dependence.

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